A Study of Yttrium [90Y] Microsphere Injection in Combination With Targeted Immunotherapy in the Treatment of HCC
brief summary
This study is A Randomized, Active-Controlled, Open-Label National Multicenter Phase 2 Registration Clinical Study of Yttrium \[90Y\] Microsphere Injection in Combination with Camrelizumab and/or Apatinib and Yttrium \[90Y\] Microsphere Injection Alone versus Conventional Transcatheter Arterial Chemoembolization (cTACE) in the Treatment of Unresectable or Non-Ablative, Non-Metastatic Hepatocellular Carcinoma (HCC). Its aim is to evaluate the efficacy and safety of yttrium \[90Y\] resin microsphere injection combined with Camrelizumab and/or apatinib compared with yttrium \[90Y\] resin microsphere injection alone in the treatment of inoperable or ablatable, non-metastatic HCC.
detailed description
This is a prospective, randomized, active-controlled, open-label, multicenter Phase 2 clinical study to evaluate the efficacy and safety of yttrium \[90Y\] microsphere injection in combination with camrelizumab and/or apatinib and yttrium \[90Y\] microsphere injection alone versus cTACE in the treatment of unresectable or non-ablative, non-metastatic HCC.
A total of at least 120 subjects with unresectable or non-ablative, non-metastatic HCC are planned to be enrolled and randomly assigned to groups A, B, C and D in a 1:1:1:1 ratio, that is, yttrium \[90Y\] microsphere injection + camrelizumab + apatinib group (A), yttrium \[90Y\] microsphere injection + camrelizumab group (B), yttrium \[90Y\] microsphere injection group (C) and cTACE group (D). The above treatment will continue until the criteria for withdrawal from study treatment are met, whichever occurs first. Subjects will receive yttrium \[90Y\] microsphere injection alone or in combination with camrelizumab and/or apatinib for up to 18 months.
The primary endpoint of the Phase 2 study is ORR assessed by BICR based on mRECIST criteria. The key secondary endpoint is PFS assessed by BICR based on mRECIST criteria.
official title
A Randomized, Active-Controlled, Open-Label Study of Yttrium [90Y] Microsphere Injection in Combination With Camrelizumab and/or Apatinib and Yttrium [90Y] Microsphere Injection Alone Versus cTACE in the Treatment of HCC